The Evaluation of the Acute Effect of Water-Pipe Smoking on the Endothelial Function and the Respiratory System

Completed

• Conditions: Healthy
• Interventions: Other: Smoking Narghile for 30 min

• Registration Number: NCT01237548
• Lead Sponsor: Rambam Health Care Campus

Brief Summary

Title: The acute effect of narghile smoking on endothelial Function, and exhaled breath condensate (EBC) and pulmonary function tests in healthy volunteers.

Objectives: To evaluate the acute effect of one cession of narghile smoking on endothelial Function, airway inflammation as assessed by exhaled breath condensate (EBC) in healthy volunteers.

Design: Prospective study evaluating these parameters before and after 30 minutes of Narghile smoking. The changes in inflammatory parameters pre and post smoking will be evaluated blindly.

Sample size: 50 participants Participant selection: Adults subjects who smoke Narghile . Intervention: Each subject will undergo evaluation including a respiratory questionnaire, endothelial Function , pulmonary function tests , exhaled breath condensate (EBC) and carboxy- hemoglobin levels . All measurements will be evaluated before and after one cession of 30 minutes narghile smoking.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-11-03
• Study First Submitted QC: 2010-11-08
• Study First Posted: 2010-11-09
• Study Start: 2011-01
• Primary Completion: 2012-10
• Study Completion: 2012-12
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-10
• Last Update Posted: 2013-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

• Age > 18 Y.O.
• Have smoked Water-pipe at least once before.

Exclusion Criteria

• Breast feeding Women.
• S/P Bacterial Or Viral infection, Last 2 weeks
• P.O. Steroids
• Water-pipe smoking, last 24 hours
• Cigarette smoking, last 6 hours
• Intensive exposure to smoke (fire), last 24 hours
• S/P Intensive Care Hospitalization, last 3 months

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
All participants	Smoking Narghile for 30 min	Normal People who have smoked Water-pipe, at least once before.

Primary Outcome Measures

Name	Time	Method
PRE - Endothelial Function as assessed by EndoPAT2000	baseline (before smoking narghile)	as assessed by EndoPAT2000. a pulse-oxymeter that asseses the endothelial function
POST - Endothelial Function as assessed by EndoPAT2000	after 30 minutes of smoking narghile	as assessed by EndoPAT2000. a pulse-oxymeter that asseses the endothelial function

Secondary Outcome Measures

Name	Time	Method
heart rate	before and immediatly after 30 min of smoking	Heart Beats count
Blood Pressure	before and immediatly after 30 min of smoking	Regular Blood Pressure assesment
carboxy- hemoglobin	before and immediatly after 30 min of smoking	Blood Test
Spirometry	before and immediatly after 30 min of smoking	Koko spirometry system
Visual Analog Score 1-10 (1=bad 10=good)	before and immediatly after 30 min of smoking	Questionnaire
Respiratory Rate	before and immediatly after 30 min of smoking
Eosinophils Count	before and immediatly after 30 min of smoking	Blood Test
Exhaled Breath Condensate	before and immediatly after 30 min of smoking	R-tubes test

Trial Locations

Locations (1)

Rambam Medical Center; 🇮🇱 Haifa, Israel